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EC number: 604-714-9 | CAS number: 149968-48-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 December 2008 to 11 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study without any restriction
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Erucamidopropyl dimethylamine
- IUPAC Name:
- Erucamidopropyl dimethylamine
- Reference substance name:
- 13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-
- EC Number:
- 604-714-9
- Cas Number:
- 149968-48-9
- Molecular formula:
- not applicable (a generic molecular formula cannot be provided for this UVCB substance)
- IUPAC Name:
- 13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-
- Test material form:
- other: solid lightbeige
- Details on test material:
- - Storage condition of test material: at room temperature, light protected
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V, The Netherlands
- Age at study initiation: Males: 18 weeks / Females: 15 weeks
- Weight at study initiation: Males: 2598g / Females: 2235-2509g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood Blocks and haysticks 4642 were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Klibba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): communitu tap water, ad libitum
- Acclimation period: 4-5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, music during the daytime period
IN-LIFE DATES: From: To: 10 to 26 December 2008
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- the test item was moistened with approximately 0.5 mL of purified water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of test item (powder) was weighed and moistened with approx. 0.5 mL of purified water before application
- Concentration (if solution): not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: left flank
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: adhesive hypoallergenic aerated semiocclusive dressing and a restrainer bandage wrapped around the abdomen
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water to clean the application site
- Time after start of exposure: 4h
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Overall 24, 48, 72hrs for each animal
- Score:
- > 0 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Mean individual score at 24, 48, 72hrs: 2.0/1.7/0.0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Overall 24, 48, 72 hrs for each animal
- Score:
- > 0 - <= 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Mean individual score at 24, 48, 72 hrs: 0.0/0.7/0.0
- Irritant / corrosive response data:
- One hour after test item exposure a very slight erythema was observed in the first treated female and in the male which progressed into a well-defined erythema at the 24-hour reading and persisted as well-defined or very slight up to the 72-hour reading in both animals. A very slight swelling was recorded in the first treated female 24 to 48 hours after removal of the dressing. Scaling was present on the skin of the male on day 7. See details in Table 7.3.1/1.
- Other effects:
- no other effects
Any other information on results incl. tables
Table 7.3.1/1:Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on skin
Score at time point after the removal of the dressing / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1h |
1/1/0 |
0/0/0 |
24h |
2/2/0 |
0/1/0 |
48h |
2/2/0 |
0/1/0 |
72h |
2/1/0 |
0/0/0 |
7 days |
0/0/0 |
0/0/0 |
10 days |
0/0/0 |
0/0/0 |
Average 24h, 48 and 72h |
2.0/1.7/0.0 |
0.0/0.7/0.0 |
Reversibility* |
c |
c |
Average time (day) for reversion** |
10 (scaling in male until day 7) |
7 |
*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
**): correspond to the last day for which skin irritation signs in the last animal were observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Erucamidopropyl dimethylamine is slightly irritating to the skin but the scores obtained are not sufficient for classification as a skin irritant according to the classification criteria of the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.
- Executive summary:
In a dermal irritation study performed according to the OECD guideline No. 404/EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) and in compliance with the GLP, 3 New Zeland Albino rabbits (one male and two females), were dermally exposed to 0.5 g of undiluted Erucamidopropyl dimethylamine (purity > 99%).
Prior to the topical application, the skin of the left flank of the rabbit was prepared with a clipper to remove the hair. 0.5 g of the test substance was placed on a surgical gauze patch and was moistened with 0.5 mL of purified water and then applied on the skin. Then the test site was covered with a semi occlusive dressing for 4 hours. Then the dressing was removed and the skin was flushed with water to clean the application site. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs, 7 and 10 days after the end of the topical application of the test patch.
The mean individual scores calculated within 3 scoring times (24, 48 and 72 hrs) were 2.0/1.7/0.0 for erythema and 0.0/0.7/0.0 for edema. One hour after the end of test item exposure a very slight erythema was observed in the first treated female and in the male which progressed into a well-defined erythema at the 24-hour reading and persisted as well-defined or very slight up to the 72-hour reading in both animals. A very slight swelling was recorded in the first treated female 24 to 48 hours after removal of the dressing. Scaling was present on the skin of the male on day 7.
No abnormal findings were observed on the treated skin of both animals, which exhibited erythema and/or edema, 7 or 10 days after the end of the treatment.
Under the test conditions, Erucamidopropyl dimethylamine is slightly irritating to the skin but the scores obtained are not sufficient for classification as a skin irritant according to the classification criteria of the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC. This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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